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First FDA warning letter for nonpayment of GDUFA fee issued against German manufacturer

11:20 AM MDT | October 8, 2013 | Deepti Ramesh

US FDA has issued a warning letter to C.P.M. ContractPharma (Feldkirchen-Westerham, Germany), a contract manufacturing firm, for failing to self-identify and pay its annual fee as required under FDA’s Generic Drug User Fee Amendments of 2012 (GDUFA). The facility has been placed on a publicly available arrears list, FDA says. “Failure to correct these violations promptly may result in regulatory action, including seizure or injunction without further notice; and the facility may also be placed on import alert such that any drug the facility...

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